Multi-center Clinical Trials of Sanjie Analgesic Capsule in Treating Endometriosis
NCT ID: NCT02031523
Last Updated: 2014-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
400 participants
INTERVENTIONAL
2013-10-31
2015-12-31
Brief Summary
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Detailed Description
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Sanjie Analgesic Capsule was approved by CFDA in 2004, produced by means of modern technology by Jiangsu Kanion Pharmaceutical Co., Ltd. The study is a multi-center, double -blind, placebo-controlled, randomized in Chinese subjects with endometriosis-associated pain to assess treatment effect and safety in the subjects treated with Sanjie Analgesic Capsule versus subjects treated with placebo.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Sanjie analgesic capsule
every 4 capsules , 3 times a day, on the first day of menstruation to start taking, taking three consecutive menstrual cycle.
Sanjie analgesic capsule
Oral, four each time, 3 times a day, on the first day of menstruation to start taking, taking three consecutive menstrual cycle.or follow the doctor's advice.
placebo
every 4 capsules, 3 times a day, on the first day of menstruation to start taking, taking three consecutive menstrual cycle.
placebo
oral，four each time, 3 times a day, on the first day of menstruation to start taking, taking three consecutive menstrual cycle. Or Follow the doctor's advice.
Interventions
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Sanjie analgesic capsule
Oral, four each time, 3 times a day, on the first day of menstruation to start taking, taking three consecutive menstrual cycle.or follow the doctor's advice.
placebo
oral，four each time, 3 times a day, on the first day of menstruation to start taking, taking three consecutive menstrual cycle. Or Follow the doctor's advice.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Female between the ages of 18 and 45 years old;
* Regular menstrual period, menstrual cycle falls in the ranging from 28 to 30 days;
* No pregnancy planning during taking study medication; use (or have their partner use) an acceptable method of birth control within the projected duration of the study ;
* Subjects must sign ICF and agree for follow up.
Exclusion Criteria
* Adnexal masses≥5cm;
* Uterine myoma≥3cm;
* Suffering from cardiovascular, hepatic, renal or hematopoietic system disease or mental illness;
* Receiving hormone therapy within 3 months prior to signing ICF;
* Receiving surgical treatment for endometriosis within 3 months prior to signing ICF;
* Subjects have a plan of pregnancy, being pregnant, breast-feeding during recent 3 months.
18 Years
45 Years
FEMALE
No
Sponsors
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Beijing Bionovo Medicine Development Co., Ltd.
OTHER
Jiangsu Kanion Pharmaceutical Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Lang Jinghe, Doctor
Role: PRINCIPAL_INVESTIGATOR
Beijing Union Medical College Hospital, Chinese Academy of Medical Sciences
Locations
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Beijing ChaoYang Hospital
Beijing, Beijing Municipality, China
Beijing Obstetrics and Gynecology Hospital,Capital Medical University
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
The General Hospital of People's Liberation Army
Beijing, Beijing Municipality, China
Hubei Provincal Hospital of TCM
Wuhan, Hubei, China
The First Hospital of Hunan University of chinese Medicine
Changsha, Hunan, China
The Maternal and Child Health Hospital of Hunan Province
Changsha, Hunan, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Jinan municipal hospital of Traditional Chinese Medicine
Jinan, Shandong, China
The Second Hospital of Shandong University of Traditional Chinese Medicine
Jinan, Shandong, China
Obstetrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Women's Hospital School Of Medicine Zhejiang University
Hangzhou, Zhejiang, China
Guangxing Hospital Of Zhejiang Chinese Medicine University
Hangzhou, Zhejiang, China
Countries
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Facility Contacts
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Gong Yingping
Role: primary
Tang Ye
Role: primary
References
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Leng JH, Duan H, Guan Z, Zhou YF, Qu H, Xu KH, Zhang SF, Zhang Q, Wang X, Lin KQ, Lang JH. Efficacy and Safety of Sanjie Analgesic Capsule in Patients with Endometriosis-Associated Pain: A Multicenter, 3:1 Randomized, Double-Blind, Placebo-Controlled Trial. Chin J Integr Med. 2024 Sep;30(9):780-787. doi: 10.1007/s11655-024-3756-y. Epub 2024 Jul 24.
Other Identifiers
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NO.2-20130301
Identifier Type: -
Identifier Source: org_study_id